GLIMEPIRIDE

Product NDC
61919-720
11-digit product format
619190720
Labeler code
61919
Product ID
61919-720_5f96a278-a1bb-4538-ad47-62c83233967e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLIMEPIRIDE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA077370
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b890b964-2cf0-4439-aaf3-900c9e3e9e49Product name120160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
d36d861f-8a90-80cc-8935-1e6be9b4c7ebProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-720-602020-01-31C16284748780-19d75b9cf-f668-f424-e053-dadaa90a57ceGLIMEPIRIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-720-60GLIMEPIRIDE60 in 1 BOTTLETABLET601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [DIRECTRX]1
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [DIRECTRX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [DIRECTRX]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGGLIMEPIRIDE TABLET [DIRECTRX]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-720GLIMEPIRIDE TABLET [DIRECTRX]1Legacy NDC, 1 package rows20151029_1c6cc8d3-a471-4862-88b9-2fe4ce50a24f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN1c6cc8d3-a471-4862-88b9-2fe4ce50a24f1
199247glimepiride 4 MG Oral TabletSCD1c6cc8d3-a471-4862-88b9-2fe4ce50a24f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-720-606191907206060 in 1 BOTTLEHistorical